# K961013: Disposable Needle Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Medelec Intl. Corp.
- Decided: Dec 20, 1996 after 282 days
- Product code: IKT (Electrode, Needle, Diagnostic Electromyograph)
- Device class: 2
- Regulation: 21 CFR 890.1385
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
60 later devices descend from it; 4 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K990015: Electrode Needles (1999), 55 descendants of its own
- K022914: Rhythmlink International Subdermal Needle Electrodes (2002), 50 descendants of its own
- K112718: Nuvasive NVM5 System (2012), 35 descendants of its own
- K123307: Nuvasive NVM5 System (2013), 33 descendants of its own
- K132694: Nuvasive NVM5 System (2014), 24 descendants of its own

Source page: https://510kreport.com/device/K961013
Methodology: https://510kreport.com/methodology